MICROFIX QUICKANCHOR ETHIBOND 212855Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705002443), received between Jul 31, 2018 and Nov 28, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K024115, K150209); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW ON (B)(6) 2022, IT WAS OBSERVED THAT THE MICROFIX QUICKANCHOR PLUS WITH 3/0 ETHIBOND (V-4 NEEDLES AND DRILL BIT) DEVICE BROKE OFF AT THE TIP UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15873261 ↗
• MalfunctionJun 3, 2022Use of Device Problem; Packaging Problem; Use of Device Problem; Packaging Problem

  IT WAS REPORTED BY THE SALES REP THAT THE MICROFIX QA+ #3/O ETH V4 DEVICE WAS RECEIVED IN A CRUSHED BOX. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT INSERTER HOLDING PIN WAS FOUND BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595121 ↗
• MalfunctionJan 21, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A THUMB LIGAMENT REPAIR PROCEDURE, IT WAS OBSERVED THAT THE DISTAL TIP OF THE CUSTOMER'S MICROFIX QUICK ANCHOR +3-0 ETHIBOND V4 WITH 1.3MM BIT BROKE DURING INSERTION. THE SALES REP STATED THAT THE BROKEN PIECES WERE REMOVED WITH NO ISSUES AND CONFIRMED THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS VERY HARD BONE AND THAT THE SURGEON WAS OFF AXIS. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE FACILITY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264877 ↗
• MalfunctionOct 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED VIA MAIL ON A MEDWATCH FORM THAT WAS GIVEN TO DEPUY MITEK BY THE REGULATORY GROUP THAT A MICROFIX QUICK ANCHOR PULLED OUT AFTER THE SURGEON IMPLANTED THE DEVICE. NEW IMPLANT WAS OPENED TO FINISH THE CASE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7937713 ↗
• MalfunctionAug 9, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE WIRE RUPTURED ON THE MICROFIX QUICK ANCHOR PLUS, W/ 3 ETHIBOND DEVICE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. THE DEVICE WAS DISCARDED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7767058 ↗
• MalfunctionJul 31, 2018Material Frayed; Material Frayed

  DURING IMPLANTATION OF 2 MINI ANCHORS THE WIRE OF TWO ANCHORS WERE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7735974 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024115, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724